Endolaserless Vitrectomy With Intravitreal IAI for PDR-Related VH (NCT02976012) | Clinical Trial Compass
UnknownPhase 1/2
Endolaserless Vitrectomy With Intravitreal IAI for PDR-Related VH
United States24 participantsStarted 2016-06
Plain-language summary
This is a phase I/II open label, randomized, interventional clinical trial. Study eyes will receive one preoperative intravitreal aflibercept injection (IAI) \<21 days but \>7 days prior to vitrectomy and one intraoperative IAI at end of surgery followed by randomization in a 1:1 ratio into either 4 mandatory postoperative q4weeks IAI followed by mandatory q8 weeks IAI for 52 weeks follow-up (q8 week Group) or 2 mandatory postoperative q4weeks IAI followed by mandatory q16 weeks IAI for 52 weeks follow-up (q16 week Group).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults age \>18 years with Diabetes Mellitus
. PDR- related vitreous hemorrhage and not of another cause
. BCVA Vision LP or better
. Investigator determination that vitrectomy indicated for PDR-related vitreous hemorrhage
. Willing and able to comply with clinic visits and study-related procedures
. Provide HIPPA and signed informed consent prior to any study procedures
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
• Ocular and systemic safety evaluation for adverse events at any time point through 52 weeks:
. A condition per investigator opinion, would preclude participation in the study (unstable medical status, cardiovascular disease, glycemic control, inability to follow up etc.)
. Participation in an investigational trial within 30 days of enrollment
. Known allergy to IAI
. Systemic anti-VEGF or pro-VEGF treatment within 4 months of enrollment
. For women of childbearing age, pregnant or lactating or intending to become pregnant within the next 3 years
. History of PRP or peripheral retinal cryopexy or peripheral retinopexy for any reason in the study eye
. History of vitrectomy in the study eye
. History or evidence for rhegmatogenous retinal detachment in the study eye